Bayer Agrees to Sell Cipro to Federal Government at 95 Cents Per Pill, Half Its Normal Price

Officials from Bayer A.G. and HHS on Oct. 24 finalized an agreement calling for the drug maker to supply the antibiotic Cipro to the federal government at nearly half its normal cost and to provide further price reductions if additional doses are needed, the New York Times reports. Under the agreement, Bayer will ship 100 million tablets of Cipro by the end of the year for 95 cents a pill and will donate an additional two million tablets beginning next week. The U.S. government had paid $1.83 per pill, with a "6-cent discount for bulk shipments" (Bradsher, New York Times, 10/25). The agreement also gives the government the option to purchase a second order of 100 million tablets at 85 cents each and a third order of the same amount at 75 cents each if it "needs to replenish its stocks" of Cipro, which has been HHS' "chief weapon" against the anthrax exposures in New York, New Jersey, Washington, D.C., and Florida. HHS Secretary Tommy Thompson said that the money for the purchase will come from $1.6 billion in counter-bioterrorism funds that the Bush administration requested last week (Dougherty, Washington Times, 10/25). The first shipment of Cipro will allow the government by January to treat 12 million people for anthrax exposure if necessary, "10 million more than supplies" can currently treat (Carroll/Winslow, Wall Street Journal, 10/25). "This agreement means that a much larger supply of this important pharmaceutical product will be available if needed," Thompson said (HHS release, 10/24).

Patent Hypocrisy?
The Cipro agreement came after Thompson threatened to override the drug's patent if Bayer did not lower the price. The Wall Street Journal reports that some analysts believed that his stance "amounted to a departure from the government's long-standing support of drug company patent rights in disputes over prices." The United States, for instance, has advocated that African countries not override the patents of HIV/AIDS treatments. "If the federal government is going to threaten to break valuable patent rights at the first sign of a crisis, it will likely serve as a significant deterrent to other drug companies who would like to do the 'right thing' and use their R&D capabilities to help the government fight bioterrorism," Nancy Myers, senior political analyst at Lehman Brothers, said. Drug companies, however, offered a "measured" opinion of the Cipro agreement, the Journal reports. A spokesperson for the Pharmaceutical Research and Manufacturers of America said, "We think [Thompson's] remarks reflect the concerns in unusual circumstances and do not set a precedent about law or policy" (Wall Street Journal, 10/25).

The Cipro Debate
Even as the government was arranging to purchase millions of tablets of Cipro, some public health officials yesterday reiterated the view that overuse of the drug could pose a threat to both individuals and the general public. The decision to distribute Cipro to 7,000 Manhattan postal workers -- "apparently unexposed" to anthrax -- increased the debate surrounding the drug, as public health officials received criticism that their "earlier inaction led to the deaths of two Washington postal employees," the Los Angeles Times reports. "This decision [in New York] is not based on knowledge that a hot letter [containing anthrax] went through a facility. Apparently it's for peace of mind," acting New Jersey Health Commissioner George DiFerdinando said. The Times also reports that the criteria for determining who receives Cipro "seem[s] random and arbitrary." The drug carries serious side effects, and doctors fear that overuse could increase bacterial resistance to the drug, weakening its effectiveness (Fiore, Los Angeles Times, 10/25). "We need to be clear that Cipro is not aspirin or some over-the-counter remedy. ... It is a strong medication, potentially harmful and should be used with discretion," D.C. Health Department Director Dr. Ivan Walks said (DeBose, Washington Times, 10/25).

Cipro et al.
Despite the attention on Cipro, health officials have said throughout the anthrax episodes that other drugs are effective in fighting the bacteria. The FDA said yesterday that it will "formally recommend" penicillin and doxycycline to treat inhalation anthrax, the most severe form of the disease that has caused three deaths this month. Cipro is now the only approved drug for inhalation anthrax, but penicillin and doxycycline -- which are less expensive and believed to carry fewer side effects -- "have been used to treat anthrax for decades" (Vedantam, Washington Post, 10/25). Meanwhile, Bayer said that it will seek FDA approval of its Avelox medicine to treat anthrax. Bristol-Myers Squibb approached the agency last week to ask that its Tequin be approved for this purpose, while Johnson & Johnson said yesterday that it will seek approval of its antibiotic Levaquin to fight anthrax. The company offered to donate 100 million tablets of Levaquin, which is similar to Cipro, to the federal government. The New York Times reports that it "usually takes the FDA months or years" to expand a drug's approval for additional ailments, but the agency "has said it will respond swiftly to bioterrorism" (New York Times, 10/25). For comprehensive public health information from the CDC on anthrax and other bioterrorism issues, please visit www.bt.cdc.gov.